Audiovisual-stimulation device improves fibromyalgia symptoms, reduces health care use

Key takeaways:

• Quality of life, depression and anxiety were among the symptoms that improved after using the device.
• The device also decreased medication use and health care visits.

An audiovisual-stimulation device improved fibromyalgia symptoms and decreased the use of medications and health care services, according to results of a pilot study presented at PAINWeek.

Richard Hanbury, MBA, chief financial officer of Sana Health, and colleagues noted that fibromyalgia (FM) has been linked to chronic pain and several adverse symptoms, including sleep fatigue, depression, mood disturbances and overall worse quality of life (QoL).

Sana Health developed an audiovisual-stimulation (AVS) mask and headphone device that coordinates pulses of light and sound, ultimately promoting relaxation and symptom recovery in the user, according to the company’s website.

According to Hanbury, the headset was given a Breakthrough Device Designation for FM by the FDA, and the company submitted a De Novo marketing request through the agency.

“We conducted this study to provide additional longitudinal data on the treatment of FM using the Sana device,” he said.

The researchers evaluated a cohort of 227 participants with FM who had used the AVS device for 28 days, measuring outcomes of FM symptoms, QoL, depression, anxiety, sleep quality, pain and health care usage.

Overall, the researchers saw improvements in:

• FM symptoms (P < = .001);
• QoL (P < = .001);
• depression (P < = .001);
• anxiety (P < = .001);
• sleep (P < = .001); and
• pain (P < = .001).

The researchers also found that the device decreased medication use by 24% (95% CI, 19%-29%) and health care visits by 10% (95% CI, 7%-15%).

“This study added to the existing evidence base for the use of the device for FM,” Hanbury said. “It is very hard with this kind of a device to carry out a sham control, hence our further need for a larger number single arm. Over time, all of [these data continue] to support the use of this device in FM.”

Hanbury explained the goal for the Sana device is “to become another tool in the toolbox for the treatment of all chronic pain and mental health conditions where anxiety and sleep disruption is a factor.”

“Our recent clinical data on neuropathic pain and PTSD [are] our next steps in this process,” he said. “Where drug treatments are limited, adding in additional tools like Sana has a great potential benefit to patients.”

References:

• Bower J, et al. The effectiveness of a novel audio-visual-stimulation device for improving symptoms and quality of life in fibromyalgia; a fully remote large-scale trial. Presented at: PAINWeek; Sept. 5-8, 2023.
• Meet Sana. https://www.sana.io/. Accessed Sept. 14, 2023.